Improving Patient Experience with Spinal Cord Stimulation: Implications of Position-Related Changes in Neurostimulation

doi:10.1111/j.1525-1403.2011.00407.x

Neuromodulation: Technology at the Neural Interface

Volume 17, Supplement 1, June 2014, Pages 36-41

https://doi.org/10.1111/j.1525-1403.2011.00407.x Get rights and content

Objectives:

The objective of this narrative review is to discuss the clinical implications of position-related changes in spinal cord stimulation and technological improvements to better meet patient needs.

Methods:

Keywords applicable to spinal cord stimulation therapy, including paresthesia perception, spinal cord position, lead impedance, and sensor technologies, were searched in the PubMed, EMBASE, and Cochrane Library databases. Literature analysis, combined with extensive clinical experience with spinal cord stimulation therapy, forms the basis of this review.

Results:

Fluctuations in paresthesia perception are largely caused by variation in the distance between the fixed electrodes and the spinal cord consequent to patient movement. Patients employ multiple strategies with varying success to manage position-related fluctuations in stimulation perception, which may result in suboptimum therapy delivery.

Conclusions:

A new type of spinal cord stimulation system that incorporates accelerometer technology to automatically adjust stimulation amplitude based on patient position may better meet patient analgesic needs and is in early clinical application.

Section snippets

INTRODUCTION

Over 40 years have passed since Shealy et al. (1) implanted a bipolar electrode to stimulate the dorsal columns for the treatment of a cancer patient in 1967. The therapy, initially called dorsal column (DC) stimulation and currently known as spinal cord stimulation (SCS), has since evolved substantially in terms of the technology, techniques, and indications. The safety and efficacy of SCS in the management of failed back surgery syndrome (FBSS) has been documented in a large number of case

CONCLUSION

The literature, as well as clinical experience, supports the need for a SCS system that automatically adapts neurostimulation to changes in the patient’s body position. A position-adaptive neurostimulation system could potentially optimize stimulation by delivering consistent paresthesia and also provide objective and quantifiable information on patients’ functional status. Such information could be useful in patient management, as well as in documenting therapeutic effectiveness. A new

Authorship Statements

Drs. Ross and Abejón have not received honoraria for their contributions to the article. Dr. Ross does not do any speaking for Medtronic, but he has received monetary compensation for attending an advisory board and teaching an implant course for Medtronic, and he has received research grants from Medtronic. Dr. Abejón has received honoraria for participating as a speaker for Boston Scientific, Medtronic, Policare and St. Jude Medical.

How to Cite This Article:

Ross, E., Abejon, D. 2011. Improving Patient Experience with Spinal Cord Stimulation: Implications of Position-Related Changes in Neurostimulation. Neuromodulation 2014; 17 (Suppl. 1): 36–41

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Cited by (40)

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources
2024, Neuromodulation
Spinal cord stimulation (SCS) thresholds are known to change with body position; however, these changes have not been fully characterized for both “constant-voltage” and “constant-current” pulse generators. This study aimed to evaluate and quantify changes in psychophysical thresholds resulting from postural changes that may affect both conventional paresthesia-based SCS and novel paresthesia-free SCS technologies.
We measured perceptual, usage, and discomfort thresholds in four body positions (prone, supine, sitting, standing) in 149 consecutive patients, with temporary lower thoracic percutaneous epidural electrodes placed for treating persistent low back and leg pain. We trialed 119 patients with constant-voltage stimulators and 30 patients with constant-current stimulators.
Moving from supine to the sitting, standing, or prone positions caused all three thresholds (perceptual, usage, and discomfort) to increase by 22% to 34% for constant-voltage stimulators and by 44% to 82% for constant-current stimulators. Changing from a seated to a supine position caused stimulation to exceed discomfort threshold significantly more often for constant-current (87%) than for constant-voltage (63%) stimulators (p = 0.01).
Posture-induced changes in SCS thresholds occurred consistently as patients moved from lying (supine or prone) to upright (standing or sitting) positions. These changes were more pronounced for constant-current than for constant-voltage pulse generators and more often led to stimulation-evoked discomfort. These observations are consistent with postural changes in spinal cord position measured in imaging studies, and with computer model predictions of neural recruitment for these different spinal cord positions. These observations have implications for the design, implantation, and clinical application of spinal cord stimulators, not only for conventional paresthesia-based SCS but also for paresthesia-free SCS.
Remote Management of Spinal Cord Stimulation Devices for Chronic Pain: Expert Recommendations on Best Practices for Proper Utilization and Future Considerations
2023, Neuromodulation
Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device management into the care of patients with SCS, including remote monitoring and remote programming.
A panel of experts in SCS met in July 2022, and additional experts contributed to the development of recommendations after the meeting via survey responses and correspondence.
Major goals of remote SCS device management were identified, including prompt identification and resolution of SCS-related issues. The panel identified metrics for remote monitoring and classified them into three categories: device-related (eg, stimulation usage); measurable physiologic or disease-related (eg, patient physical activity or pedometry); and patient-reported (eg, sleep quality and pain intensity). Recommendations were made for frequency of reviewing remote monitoring metrics, although providers should tailor follow-up to individual patient needs. Such periodic reviews of remote monitoring metrics would occur separately from automatic monitoring system notifications (if key metrics fall outside an acceptable range). The guidelines were developed in consideration of reimbursement processes, privacy concerns, and the responsibilities of the care team, industry professionals, manufacturers, patients, and caregivers. Both existing and needed clinical evidence were covered, including outcomes of interest for future studies.
Given the expansion of SCS device capabilities, this document provides critical guidance on best practices for using remote device management, although medical necessity should drive all remote monitoring decisions, with individualized patient care. The authors also describe the potential of these emerging technologies to improve outcomes for patients with SCS, although more clinical evidence is needed.
A Pilot Study Comparing Algorithmic Adaptive Conventional Stimulation with High-Dose Stimulation in Chronic Pain Patients
2022, World Neurosurgery
Spinal cord stimulation is an effective method of treatment for chronic pain. We previously showed that programming using accelerometry was advantageous for paresthesia-based stimulation. However, programming can be labor intensive.
Here we focus on standardized programming for both accelerometer-based paresthesia-induced programming (termed “shuffle”) and high-dose (HD) subthreshold programming with stimulation delivered over the T9-10 interspace.
In this prospective cross-over study, patients received 4 weeks of shuffle programming and 4 weeks of HD programming in a randomized order. In both intervals, contacts overlying T9-10 were programmed. Pain scales with measurements of activity and sleep were collected at the end of each study arm and compared with preoperative baseline scores.
Twelve patients were enrolled, with 10 patients completing this study. Compared with baseline, during the HD study period, significant improvements were seen in worst pain of week (P = 0.03) and current pain (P = 0.04) as rated on Numeric Rating Scale scores and walking on the Activity Test (P = 0.012). No difference was seen from baseline compared with shuffle stimulation or in shuffle stimulation compared with HD stimulation.
In this pilot study, we demonstrated that HD stimulation at T9-10 is superior to algorithmic programming of paresthesia-based stimulation. These results compared with our previous work with shuffle suggest that paresthesia-based stimulation may necessitate stimulation of additional contact locations and additional programming to optimize. This algorithmic programming of paresthesia-based stimulation continues to warrant exploration.
Quantitative Sensory Testing of Spinal Cord and Dorsal Root Ganglion Stimulation in Chronic Pain Patients
2021, Neuromodulation
Background/Objectives: The physiological mechanisms underlying the pain-modulatory effects of clinical neurostimulation therapies, such as spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS), are only partially understood. In this pilot prospective study, we used patient-reported outcomes (PROs) and quantitative sensory testing (QST) to investigate the physiological effects and possible mechanisms of action of SCS and DRGS therapies.
Materials and Methods: We tested 16 chronic pain patients selected for SCS and DRGS therapy, before and after treatment. PROs included pain intensity, pain-related symptoms (e.g., pain interference, pain coping, sleep interference) and disability, and general health status. QST included assessments of vibration detection theshold (VDT), pressure pain threshold (PPT) and tolerance (PPToL), temporal summation (TS), and conditioned pain modulation (CPM), at the most painful site.
Results: Following treatment, all participants reported significant improvements in PROs (e.g., reduced pain intensity [p < 0.001], pain-related functional impairment [or pain interference] and disability [p = 0.001 for both]; better pain coping [p = 0.03], sleep [p = 0.002]), and overall health [p = 0.005]). QST showed a significant treatment-induced increase in PPT (p = 0.002) and PPToL (p = 0.011), and a significant reduction in TS (p = 0.033) at the most painful site, but showed no effects on VDT and CPM. We detected possible associations between a few QST measures and a few PROs. Notably, higher TS was associated with increased pain interference scores at pre-treatment (r = 0.772, p = 0.009), and a reduction in TS was associated with the reduction in pain interference (r = 0.669, p = 0.034) and pain disability (r = 0.690, p = 0.027) scores with treatment.
Conclusions: Our preliminary findings suggest significant clinical and therapeutic benefits associated with SCS and DRGS therapies, and the possible ability of these therapies to modulate pain processing within the central nervous system. Replication of our pilot findings in future, larger studies is necessary to characterize the physiological mechanisms of SCS and DRGS therapies.
Randomized Prospective Study in Patients With Complex Regional Pain Syndrome of the Upper Limb With High-Frequency Spinal Cord Stimulation (10-kHz) and Low-Frequency Spinal Cord Stimulation
2021, Neuromodulation
The objective of this prospective randomized study of cases and controls was to evaluate the efficacy of treatment with low-frequency spinal cord stimulation (LF-SCS) and 10 kHz spinal cord stimulation (10-kHz SCS) in patients diagnosed with complex regional pain syndrome type I (CRPS) with upper limb involvement.
Fifty patients were randomized to receive conventional treatment or SCS with a commercially available low-frequency or 10-kHz system. Patients were assessed at 1, 3, 6, and 12 months. The primary endpoint was at 12-months post permanent implantation of the SCS devices. Outcome measures assessed included: Numerical Rating Scale (NRS), 12-Item Short-Format Health Survey (SF-12), Oswestry Disability Index (ODI), Study Sleep Scale medical outcomes (MOS-SS), Douleur Neuropathique 4 questions pain questionnaire (DN4), Patient Global Impression Scale on the impact of treatment improvement (PGI-I), Clinician Global Impression Scale on the impact of improving the patient (CGI-I).
Forty-one patients were finally included in the analysis, 19 patients in the conventional treatment group, 12 in the LF-SCS group, and 10 in the 10-kHz SCS group. At the primary endpoint, patients treated with LF-SCS presented improvements in the NRS and DN4 outcomes around 2.4 and 1.5 times above the minimal clinically important difference (MCID) thresholds. At the primary endpoint, patients treated with 10-kHz SCS presented improvements in the NRS and DN4 outcomes around 2 and 1.4 times above the MCID thresholds.
Patients experienced considerable improvement after SCS. The results show that LF-SCS has very good results when compared with conventional treatment. The results obtained with 10-kHz SCS are encouraging, with the advantages of the absence of paresthesia making it an alternative in the treatment of CRPS.
High-frequency spinal cord stimulation treatment attenuates the increase in spinal glutamate release and spinal miniature excitatory postsynaptic currents in rats with spared nerve injury-induced neuropathic pain
2020, Brain Research Bulletin
High-frequency spinal cord stimulation (HFSCS) at 10 kHz provides paresthesia-free treatment for chronic pain. However, the underlying mechanisms of its action have not been fully elucidated. The aim of the present study was to investigate the effect of HFSCS treatment on spinal glutamate release and uptake in spared nerve injury (SNI) rats. HFSCS was applied to the T10/T11 spinal cord 3 days after SNI. The concentration of spinal glutamate, glutamate transporter activity and miniature excitatory postsynaptic currents (mEPSCs) from neurons in lamina II were evaluated. HFSCS treatment alleviated SNI pain induced by mechanical and cold allodynia. HFSCS treatment also partially restored altered spinal glutamate uptake activity, the levels of spinal glutamate, and the frequency of mEPSCs following SNI. In conclusion, HFSCS treatment attenuated SNI-induced neuropathic pain and partially restored the altered glutamate uptake after SNI.

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^¹: Assumes a 1000 Ω impedance.

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This supplement was made possible by an unrestricted educational grant from MedtronicImproving Patient Experience with Spinal Cord Stimulation: Implications of Position-Related Changes in Neurostimulation

Objectives:

Methods:

Results:

Conclusions:

Section snippets

INTRODUCTION

CONCLUSION

Authorship Statements

How to Cite This Article:

Pain

Neuromodulation

Neuromodulation

Pain

Neuromodulation

Neuromodulation

Neuromodulation

Am J Cardiol

Pain

Chest

Heart Fail Clin

Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report

Anesth Analg

Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial

Neurosurgery

The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation

Neurosurgery

Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: a systematic review and analysis of prognostic factors

Spine

Is impedance a parameter to be taken into account in spinal cord stimulation?

Pain Physician

This supplement was made possible by an unrestricted educational grant from Medtronic
Improving Patient Experience with Spinal Cord Stimulation: Implications of Position-Related Changes in Neurostimulation